Tislelizumab with Azacitidine in the Treatment of R/R AML
Megadott ok: withdrawn
Key facts
- Where
- Tianjin, KínaSee the site
- Phase
- 1/2. fázis
Where in Kína
- HBDHTianjin, KínaNo longer taking part
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06586099
- Record updated
- 2024. szeptember 19.
- Original description
Acute myeloid leukemia(AML) is a clonal hematological malignancy. 50%-90% adult AML patients can achieve complete remission(CR) after standard induction chemotherapy,but 10%-25% patients cannot achieve CR, which is called 'primary refractory disease'.Most of patients who achieved CR will relapse during the next 3 years, and the prognosis is poor.So refractory and relapse diseases are still the hotspot of clinical research.Immunologic escape is one of the mechanisms for tumor cells to survive from chemotherapy. Studies have shown that PD1 and PDL1 levels are upregulated in AML patients, the same phenomenon was observed after the treatment of demethylating agents such as azacytidine. Combination of PD1 blockades with azacytidine may improve the efficacy of the treatment.Read full original descriptionShow less
Prospective, Open-label, Single Arm Trial to Evaluate Efficacy and Safety of Tislelizumab with Azacitidine in the Treatment of Refractory/relapsed Acute Myeloid Leukemia
Acute myeloid leukemia(AML) is a clonal hematological malignancy. 50%-90% adult AML patients can achieve complete remission(CR) after standard induction chemotherapy,but 10%-25% patients cannot achieve CR, which is called 'primary refractory disease'.Most of patients who achieved CR will relapse during the next 3 years, and the prognosis is poor.So refractory and relapse diseases are still the hotspot of clinical research.Immunologic escape is one of the mechanisms for tumor cells to survive from chemotherapy. Studies have shown that PD1 and PDL1 levels are upregulated in AML patients, the same phenomenon was observed after the treatment of demethylating agents such as azacytidine. Combination of PD1 blockades with azacytidine may improve the efficacy of the treatment.
Inclusion: diagnosis of AML according to FAB or WHO criteria; refractory or morphological relapsed AML; age over 18 years old; ECOG PS 0-2; written informed consent.
Exclusion: antecedent stem cell transplantation; solitary extramedullary relapsed disease; other hematological diseases; with other active organ malignancy(needing treatment); active heart diseases; acute promyelocyte leukemia; AML with BCR_ABL positive; acute panmyelosis with myelofibrosis or sarcoma; unfit for enrollment after investigator's evaluation.